510(k) K243576 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port
| Applicant | Smith & Nephew Medical, Ltd., Hull, GB |
| Decision | Substantially Equivalent, Feb 18, 2025 |
| Received | Nov 19, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243576
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.